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Siemens developed the Clinical Phosphorus Spectroscopy Option for the Magnetom Vision system to allow the non-invasive in vivo analysis of energy metabolites in muscle, liver and heart tissue. The package allows observation of phosphocreatine (PCr), inorganic phosphate (Pi), Adenosine triphosphate (ATP), phosphomonoester (PME), phosphodiester (PDE) levels. Information provided by phosphorus spectroscopy data allows evaluation of the energetic state of examined tissues and intracellular pH, measured from the chemical shift of Pi.

The new Clinical Phosphorus Spectroscopy Option for the MAGNETOM VISION consists of hardware/software extensions, a new rf surface coil, and a new quality assurance phantom.

I am sorry, but your request could not be fulfilled. The document does not contain the necessary information to answer your questions because it is a very old 510(k) summary (from 1996) and describes a "Clinical Phosphorus Spectroscopy Option" for an MRI system, not an AI/ML device. Therefore, a study that proves the device meets the acceptance criteria is not included in the provided text. Additionally, the information requested in your prompt (such as "sample size", "ground truth", "reader study", etc.) is typically associated with the evaluation of AI/ML-driven devices and is not applicable to the traditional medical device described in this document.

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